One out of two adults in Canada is currently overweight and therefore at increased risk for a number of medical conditions including diabetes, high blood pressure, heart attacks and stroke. Obesity is less prevalent in populations consuming large amounts of dietary fibre, suggesting that fibre intake could play an important role in prevention and progression of obesity and diabetes and other conditions. Several studies have suggested that fibre has a positive effect on blood sugar and may help lower body weight.

The purpose of this study is to help better understand the effect of adding fibre supplementation to a low calorie diet on blood sugar control and weight loss. The investigators hypothesize that blood sugar control will improve in participants in the fibre supplementation group.

Men and women, with stable Type 2 Diabetes (e.g. no medication change in the last 3 months), between 18 - 75 years of age, and with a Body Mass Index (BMI) between 27 - 60 kg/m2 can participate in this study.

Participant is taking any of the following natural health products that can alter body weight or appetite: ephedra, synephrine, green tea extracts, daily use of bulk fibre laxatives (e.g. psyllium, glucomannan)

Participant not eligible for enrolment in a medically supervised LCD program at the Wharton Medical Clinic (WMC only accepts patients by referral from a family physician. To be eligible patients must have a BMI ≥ 30 or ≥ 27 with at least one obesity related comorbidity.)

Patient with a past history of severe hypoglycaemia (as defined by the Diabetes Control and Complications Trial (DCCT)) whether or not on insulin, sulfonylureas and non-sulfonylurea secretogogues

Patient with documented hypoglycemic unawareness, whether or not on insulin, sulfonylureas and non-sulfonylurea secretogogues

Positive urine pregnancy test, pregnancy, breast feeding, or hormonal contraceptives started in the last 6 months prior to the start of the study

Absence of a highly effective method of birth control for female of childbearing potential (premenopausal or not surgically sterile) OR does not plan to use contraception for the duration of study participation AND does not agree to periodic urine pregnancy testing during the study. ICH M3 defines a highly effective method of birth control as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.

Substance abuse: tobacco (including those who have quit smoking in the last 12 months), Cannabis sativa, or other controlled substances use

Any allergies to study product ingredients including dairy, whey, rice, soy and or coconut.

Current diagnosis or history of gastrointestinal diseases or disorders (with the exception of Irritable Bowel Syndrome and GERD at the discretion of qualified investigator).

Heart failure

Substantial neurological or psychological illness within the last 6 months (at the discretion of qualified investigator)

Contraindications to LCD

any major surgery that is, at the time of screening, planned to take place during the study

history of drug or alcohol dependency within six months prior to signing the informed consent form.

history of active malignancy (exceptions at the discretion of qualified investigator e.g. squamous cell carcinoma), chronic inflammatory disorder, or chronic infections which would interfere with protocol completion

history of CV event or angina within 6 months (with the exception of stable angina at the discretion of qualified investigator)

history of active gall bladder disease where the gallbladder was not removed

inflammatory bowel disease

type 1 diabetes

significant renal impairment eGFR < 50

porphyria

cirrhosis

patients deemed unable to comprehend or comply with the diet and/or,

unable to attend program follow up visits

Participant cannot fully understand all instructions in English.

Any other medical, social or geographic condition, which, in the opinion of the qualified investigator would not allow safe completion of the protocol.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644201